Observe Medical AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000017468
- Devices
- 24
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Search and filter all 24 devicesCompany details
- EUDAMED SRN
- SE-MF-000017468
- EU VAT number
- SE556723203701
- EUDAMED status
- Active
- EUDAMED registered name
- Observe Medical AB
- Registered address
- 4, Krokslätts Parkgata, 431 68, Mölndal, Sweden
- Website
- www.observemedical.com
- [email protected]
- PRRC contact
- Jenny Wennerberg
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 28 Mar 2027
Intertek Medical Notified Body AB 2862 1 certificate
- 28620123041 Expiring
Quality management system EU MDR
- Issued
- 22 Jun 2023
- Expires
- 28 Mar 2027
From the company website
CE-marked closed urine meters for hourly diuresis in critical care. The UnoMeter range, from a Nordic medtech manufacturer.
Frequently asked questions
How many devices does Observe Medical AB have in the registry?
The registry currently lists 24 devices for Observe Medical AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Observe Medical AB's devices?
Among its 24 most recently registered devices, Observe Medical AB has devices listed in EUDAMED (24 devices).
What risk classes do Observe Medical AB's devices fall under?
Among its 24 most recently registered devices, the classes recorded for Observe Medical AB's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Observe Medical AB?
EUDAMED lists 1 certificate for Observe Medical AB (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 22 Jun 2023.
What are the newest devices from Observe Medical AB in the registry?
The most recently registered devices listed for Observe Medical AB include UnoMeter™ Original Exchange bag, UnoMeter™ 500, UnoMeter™ Safeti™ Max and UnoMeter™ Safeti™ Plus.